MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-G-511
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
It was reported that at some point in the past year, the ps post separated from the insert and the insert from the tibial baseplate while in the patient.Fractured insert.The initial surgery was done for right tka on (b)(6)2019.The revision surgery was done (b)(6).
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations, which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a cementless right triathlon tritanium total knee arthroplasty at some point in the past because i was able to see an x-ray with the implant in place, albeit undated.I cannot confirm the revision procedure as i have no office notes, operation notes or post revision x-rays.The root cause of this event cannot be determined with certainty.The causes of polyethylene failure are multifactorial.One factor is surgical technique in the way the implant is positioned and aligned and whether or not proper stability and kinematics of the knee was restored.In this case the tibial component is in significant varus and with a significantly increased posterior slope.These factors alone can contribute to polyethylene failure both at the post and at the locking mechanism.Patient factors including lifestyle, activity level and bmi can also contribute, as well as implant factors" product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to crack/fracture.Visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a cementless right triathlon tritanium total knee arthroplasty at some point in the past because i was able to see an x-ray with the implant in place, albeit undated.I cannot confirm the revision procedure as i have no office notes, operation notes or post revision x-rays.The root cause of this event cannot be determined with certainty.The causes of polyethylene failure are multifactorial.One factor is surgical technique in the way the implant is positioned and aligned and whether or not proper stability and kinematics of the knee was restored.In this case the tibial component is in significant varus and with a significantly increased posterior slope.These factors alone can contribute to polyethylene failure both at the post and at the locking mechanism.Patient factors including lifestyle, activity level and bmi can also contribute, as well as implant factors"the event was not confirmed.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that at some point in the past year, the ps post separated from the insert and the insert from the tibial baseplate while in the patient.Fractured insert.The initial surgery was done for right tka on (b)(6) 2019.The revision surgery was done (b)(6).

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20133844
• Report Number: 0002249697-2024-01203
• Device Sequence Number: 7221699
• Product Code: MBH
• UDI-Device Identifier: 07613327050783
• UDI-Public: 07613327050783
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 5532-G-511
• Device Lot Number: VV15TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown